MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK 13.8MM STD OFFSET; OTHER PRODUCTS

Catalog Number 101201138

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Abscess (1690); Unspecified Infection (1930); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)

Event Date 08/25/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Occupation: lawyer.(b)(4).If information is.

Event Description

Patient reported his pinnacle mom hip was revised in 2012 due to "failed hip".Patient stated he is currently house-bound and not able to walk.Update ad 11 apr 2019.(b)(4) has been re-opened under (b)(4) due to receipt of unf and medical records.Unf provided the doi and dor.After review of medical records, the patient was revised on (b)(6) 2012 for bilateral psoas abscess and bilateral total hip infections.Operative notes reported that a dense bursitis was encountered.Aggressive posterior hip debridement was carried out with femoral components noted to be loose and after clearing the soft tissues around the proximal femur, and anteriorly synovitis was noted.Medical records also mention that per anesthesia report to hbs, prolonged procedure (8hrs) complicated by need for intra-op ketamine gtts for adequate pain control and sedation.Doi: (b)(6) 2006; dor: (b)(6) 2012; left hip.The patient has bilateral hip implants, please see (b)(4) for the right hip.

Manufacturer Narrative

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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.H10 additional narrative: corrected: h6.Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 will be filed as appropriate.

• Brand Name: TRI-LOCK 13.8MM STD OFFSET
• Type of Device: OTHER PRODUCTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9592891
• MDR Text Key: 188668517
• Report Number: 1818910-2020-01839
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K872878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101201138
• Device Lot Number: AV3C81000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR