MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 28IDX46OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-28-146
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Revision of pe hip-inlay unknown side after about 4 years because of pe wear.Doi: unknown, dor: (b)(6) 2021.
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.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
Medical records reviewed: on (b)(6) 2017, the patient underwent a primary right hip arthroplasty due to advanced coxarthrosis with existing dysplasia.Depuy acetabular cup, poly liner, depuy corail stem, and metal head were implanted.There were no indicated intra-operative complications.On (b)(6) 2021, the patient underwent a right hip revision to address poly liner wear.The surgeon noted subluxation that was causing noises.The head and liner were revised.There were no indicated intra-operative complications.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the joint injury.
Event or Problem Description
Additional information received indicated that the affected side was the right hip.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : examination of the returned device found evidence to support disassociation of the liner from the cup while implanted.This device was manufactured on 14-nov-2016.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : 1) quantity manufactured: 40.2) date of manufacture: nov 2016.3) any anomalies or deviations identified in dhr: 2 parts scrapped at the cleaning step.4) expiry date: 31-oct-2021.5) ifu reference: (b)(4).

• Brand Name: PINN MAR +4 10D 28IDX46OD
• 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: 11920583
• Report Number: 1818910-2021-11570
• Device Sequence Number: 19650724
• Product Code: LPH
• UDI-Device Identifier: 10603295013440
• UDI-Public: 10603295013440
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• 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,Followup,Followup
• Report Date (Section B): 05/18/2021

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 Expiration Date: 10/31/2021
• Device Model Number: 1219-28-146
• Device Catalogue Number: 121928146
• Device Lot Number: H09044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 06/08/2021; 06/14/2021; 07/10/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/15/2021; 06/23/2021; 06/30/2021; 07/13/2021
• 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 28 +1.5 GR; CORAIL2 STD SIZE 13; PINNACLE BANTAM ACET CUP 46MM; ARTICUL/EZE BALL 28 +1.5 GR; CORAIL2 STD SIZE 13; PINNACLE BANTAM ACET CUP 46MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR