UNKNOWN HIP ACETABULAR LINERS

Report

Report Number: 1818910-2019-104832
Event Type: Malfunction
Date Received: September 17, 2019
Report Date: August 30, 2019
Manufacturer: DEPUY ORTHOPAEDICS INC US
Product Code: KWY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

LITERATURE ARTICLE RECEIVED ENTITLED "ANALYSIS OF TEMPORAL WEAR PATTERNS OF POROUS-COATED ACETABULAR COMPONENTS: DISTINGUISHING BETWEEN TRUE WEAR AND SO-CALLED BEDDING IN." LITERATURE ARTICLE ENTITLED, ¿ANALYSIS OF TEMPORAL WEAR PATTERNS OF POROUS-COATED ACETABULAR COMPONENTS: DISTINGUISHING BETWEEN TRUE WEAR AND SO-CALLED BEDDING-IN¿ BY CHRISTI J. SYCHTERZ, M.S.E., ET AL, PUBLISHED BY THE JOURNAL OF BONE AND JOINT SURGERY (1999), VOL. 81-A. NO. 6, PP. 821-830 WAS REVIEWED FOR MDR REPORTABILITY. THE PURPOSE OF THE CURRENT STUDY WAS TO COMPARE THE WEAR PERFORMANCE OF THE INITIAL MODULAR ACETABULAR CUP DESIGN (SO-CALLED FIRST-GENERATION COMPONENTS) OF THREE DIFFERENT MANUFACTURERS WITH THAT OF A SO-CALLED SECOND-GENERATION COMPONENT MADE BY ONE OF THE MANUFACTURERS. A TWO-DIMENSIONAL COMPUTERIZED RADIOGRAPHIC METHOD WAS USED TO ANALYZE 1300 RADIOGRAPHS OF 315 HIPS THAT WERE FOLLOWED FOR 3.0 TO 10.5 YEARS. TEMPORAL PENETRATION BY THE HEAD IN THE THREE GROUPS OF FIRST-GENERATION CUPS WAS COMPARED WITH PENETRATION IN THE GROUP OF SECOND-GENERATION CUPS. MULTIPLE LINEAR REGRESSION ANALYSIS WAS USED TO MODEL PENETRATION-VERSUS-TIME DATA AS A LINE FOR EACH GROUP. THE SLOPE OF EACH REGRESSION LINE INDICATED THE TRUE RATE OF WEAR, AND THE INTERCEPT OF THE REGRESSION LINE INDICATED THE AMOUNT OF BEDDING-IN. THE AUTHORS ANALYZED 1300 RADIOGRAPHS OF 315 HIPS. EACH PATIENT HAD A RADIOGRAPH MADE WITHIN THE FIRST FEW WEEKS AFTER THE OPERATION. THE OTHER RADIOGRAPHS WERE MADE AT SUBSEQUENT CLINICAL FOLLOW-UP EXAMINATIONS. IDEALLY, THE FOLLOW-UP EXAMINATIONS WERE SCHEDULED AT ANNUAL OR BIANNUAL INTERVALS. ALL PATIENTS HAD A PRIMARY TOTAL HIP REPLACEMENT WITH INSERTION OF A POROUS-COATED FEMORAL STEM (AML) WITHOUT CEMENT, A THIRTY-TWO-MILLIMETER-DIAMETER FEMORAL HEAD (DEPUY), A STANDARD ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE LINER, AND ONE OF FOUR DIFFERENT ACETABULAR COMPONENTS. (FOR ONE TYPE OF ACETABULAR CUP, A SO-CALLED ENHANCED POLYETHYLENE LINER WITH INCREASED CRYSTALLINITY WAS AVAILABLE IN ADDITION TO THE STANDARD POLYETHYLENE LINER, BUT THESE ENHANCED LINERS WERE NOT INCLUDED IN THIS ANALYSIS.). THE FIRST GROUP, WHICH WAS FOLLOWED FOR 4.6 TO 10.5 YEARS, COMPRISED 104 HIPS THAT HAD BEEN TREATED WITH AN ARTHROPOR CUP (JOINT MEDICAL PRODUCTS, STAMFORD, CONNECTICUT). THE SECOND GROUP, FOLLOWED FOR 3.1 TO 9.5 YEARS, CONSISTED OF 127 HIPS THAT HAD BEEN TREATED WITH A TRI-LOCK CUP (DEPUY) WITH LINERS STERILIZED BY GAMMA IRRADIATION IN AIR. THE THIRD GROUP, WHICH WAS FOLLOWED FOR 3.2 TO 7.9 YEARS, CONSISTED OF THIRTY-SEVEN HIPS IN WHICH A HARRIS-GALANTE-I CUP (ZIMMER, WARSAW, INDIANA). A FOURTH GROUP, FOLLOWED FOR 3.0 TO 6.0 YEARS, CONSISTED OF FORTY-SEVEN HIPS THAT HAD HAD INSERTION OF A DURALOC CUP (DEPUY) AND STERILIZED BY GAMMA IRRADIATION IN AIR. AS EXPECTED, THE AMOUNT OF PENETRATION INCREASED IN EACH POSTOPERATIVE YEAR (FIG. 6). DURING THE FIRST FEW YEARS, THIS MOVEMENT WAS DUE TO BOTH BEDDING-IN AND POLYETHYLENE WEAR. WITH TIME, HOWEVER, BEDDING-IN DIMINISHED AND PENETRATION RESULTED MAINLY FROM THE REMOVAL OF POLYETHYLENE PARTICLES FROM THE LINER3,6,8,15,16. THE LARGE STANDARD DEVIATIONS WERE AN INDICATION OF THE WIDE VARIETY OF INDIVIDUAL WEAR PATTERNS. THE RATE OF PENETRATION BY THE FEMORAL HEAD WAS HIGHEST IN THE FIRST TWO POSTOPERATIVE YEARS AND THEN DECREASED WITH TIME. THE AUTHORS DO NOT STUDY OR MENTION PATIENT HARMS, MEDICAL INTERVENTIONS, SURGICAL COMPLICATIONS, OR REVISIONS OF THE LISTED COMPONENTS. THEY CONCLUDE THAT THE HIGH FEMORAL HEAD PENETRATION WITHIN THE FIRST TWO YEARS POSTOPERATIVELY IS DUE TO INITIAL BEDDING IN. THE ADDITIONAL FEMORAL HEAD PENETRATION IS DUE TO TRUE POLYETHYLENE WEAR. THIS STUDY REFLECTS ACCUMULATED, RETROSPECTIVE DATA WITH RADIOGRAPHICALLY IDENTIFIED POLYETHYLENE WEAR DUE TO FEMORAL HEAD PENETRATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
872572	UNKNOWN HIP ACETABULAR LINERS	HIP ACETABULAR LINERS	KWY	DEPUY ORTHOPAEDICS INC US

Patients

Seq	Age	Sex	Outcome	Treatment
1