MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 36IDX62OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1219-36-062

Device Problem Off-Label Use (1494)

Patient Problems Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/14/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).

Event Description

Claim letter received alleging pain, inability to walk without crutches, inability to move, trouble sleeping, spasms, discomfort, suffering, significant loss of amenity.Doi: (b)(6) 2017 - dor: (b)(6) 2018 (right hip).Email notification from (b)(6) received alleging infection.Primary surgery date has been updated to (b)(6) 2015 and revision date to (b)(6) 2016.The revision on (b)(6) 2017 noted on the kennedys appendix b matches with the second stage revision mentioned on the original claim letter.It was indicated that during this date, the infection had settled and the client's hip was now put back in place.It is unknown if the definitive implants are from depuy.It should be noted that around ten days after the definitive's were implanted, the patient had experienced pain again.It was also indicated that this claim is not actively litigated.Doi: (b)(6) 2015 - dor: (b)(6) 2016 (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 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 was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MAR NEUT 36IDX62OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9757323
• MDR Text Key: 191110079
• Report Number: 1818910-2020-06061
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014492
• UDI-Public: 10603295014492
• Combination Product (y/n): N
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 1219-36-062
• Device Catalogue Number: 121936062
• Device Lot Number: 535046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 03/17/2020
• Supplement Dates FDA Received: 03/04/2020; 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 05801441/G6106999; 121720500/D15111358; 121732062/3500330; 121740500/D14073504; 63642136/G6166311; 66017569/84294526; 66017569/85294526; 963203000/D16072495
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR