MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-052

Device Problems Loss of Osseointegration (2408); Malposition of Device (2616)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 07/25/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Unf and medical records received.After review of medical records, the patient was presented with grinding and groin pain.The patient was then revised for failed metal on metal total hip replacement left, possible acetabular component loosening.Operative notes reported that a fluid collection with evidence of metallosis was encountered.Necrotic tissues were debrided, which consisted of trochanteric bursa, which was seen within metal debris.There was minimal evidence of taper corrosion.Prior to this examination of the cup showed it to be quite vertical.It was also quite anteverted also.Operative notes did mention that the cup was loose as indicated on pre-op diagnosis.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

Product complaint # (b)(4).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.   h10 additional narrative: this is a duplicate report of mfr# 1818910-2018-77586.Mfr# 1818910-2020-05626 is being retracted as it a report duplication.Mfr# 1818910-2018-77586 will be kept for investigation purposes.

• Brand Name: PINNACLE 100 ACET CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9739118
• MDR Text Key: 188667691
• Report Number: 1818910-2020-05626
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008552
• UDI-Public: 10603295008552
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-01-052
• Device Catalogue Number: 121701052
• Device Lot Number: A2EFF1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR