MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-060
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Surgeon is reporting a disassociation of inlay from cup.Left side affected.Doi: (b)(6) 2013, dor: (b)(6) 2020.Revision of inlay and head.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
On (b)(6) 2011, left hip resurfacing, status post cancellous bone grafting on cranial acetabular rim.On (b)(6) 2013, the patient had an implantation of a cementless total hip replacement to address osteoarthritis, reduction in walking distance and mobility, and pain.Extensive scarring was noted.On (b)(6) 2020, the patient was revised due to inlay dislocation.Prior to surgery the patient reported having pain, creaking sound in hip.Only the insert and head were revised.The insert was found to be disassociated from the cup.Depuy components were used during this procedure.Preoperative radiographs noted decentering of the prosthetic head in the cup consistent with inlay fracture/wear, but no mention of this in the actual revision operative notes.Doi: (b)(6) 2013.Dor: (b)(6) 2020.Affected side: left hip.
Additional Manufacturer Narrative
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 : a device manufacturing records evaluation (mre) was performed.No related deviations or anomalies were identified.There are no non-conformances associated with this product/lot combination.Device history review : a device manufacturing records evaluation (mre) was performed.No related deviations or anomalies were identified.There are no non-conformances associated with this product/lot combination.

• Brand Name: PINN MAR NEUT 32IDX60OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11329261
• Report Number: 1818910-2021-02987
• Device Sequence Number: 858420
• Product Code: LPH
• UDI-Device Identifier: 10603295013945
• UDI-Public: 10603295013945
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1219-32-060
• Device Catalogue Number: 121932060
• Device Lot Number: 392948
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/24/2021; 04/26/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/02/2021; 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 32 +17 WH; PINNACLE 100 ACET CUP 60MM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR