FDA Adverse Event
Other
Summary report: N
ZIMMER COLLAGEN REPAIR PATCH
MDR report key: 643446
·
Received October 24, 2005
Report
- Report Number
- 9617613-2005-00032
- Event Type
- Other
- Date Received
- October 24, 2005
- Date of Event
- September 26, 2005
- Manufacturer
- TISSUE SCIENCE LABORATORIES, PLC
- Product Code
- FTM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE SURGEON REPAIRED A LARGE ROTATOR CUFF TEAR WITH THE ZIMMER COLLAGEN REPAIR PATCH. FIVE WEEKS LATER THE PT WAS SEEN IN THE SURGEONS OFFICE WHERE THE SURGEON NOTICED REDDENING AND YELLOWISH TINT OF THE SKIN OVER THE INCISION SITE. UPON PRESSING ON THE SHOULDER, THE INCISION OPENED AND PURULENT MATTER DRAINED FROM THE INCISION. THE SURGEON RE-OPERATED THE NEXT DAY TO DEBRIDE THE DEHISCED WOUND AND UPON OPENING THE SHOULDER NOTICED `GELATINOUS' MATERIAL WHERE THE ZIMMER COLLAGEN REPAIR PATCH WAS PLACED. THE PT WAS TREATED INTEROPERATIVELY WITH ANTIBIOTICS AND WHEN A CULTURE WAS OBTAINED THE LAB REPORT WAS NEGATIVE FOR BACTERIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER COLLAGEN REPAIR PATCH | PORCINE DERMAL IMPLANT | FTM | TISSUE SCIENCE LABORATORIES, PLC | Z02 | 04B36-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |