MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 32IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-156
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon reported to bfarm: "inlay dislocation of the right hip after primary cementless depuy hip tep right 01/2017.Now revision of right hip with cup change (müller supporter cup, size 54, 4-times screw-retained, cemented triloc-2- pe cup size 52/32, merete bioball 2xl sleeve 10.5mm, ceramic head ø 32mm) and allogeneic bone graft acetabulum".Doi: (b)(6) 2017.Dor: (b)(6) 2022.Right hip.
Additional 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.
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: added: b5.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
Additional information received: a.Was there any surgical delay? what was the duration of the delay? 168 min due to difficult surgery conditions.B.Was the patient experiencing any adverse symptoms that led to the revision surgery? pain plus rubbing phenomenon right hip.C.Can you please confirm if the liner disassociated from the cup or dislocated from the head? if dislocated from the head, please provide product details of the head liner disassociated from the cup.D.Was there any alleged deficiency to the stem as to why it was revised? if yes, please provide details.Stem was no revised; no allegation against it.Patient dob: 1968.
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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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 # (b)(4).Investigation summary, the device associated with this report was received for analysis.Based in the visual examination of the part, the disassociation event could be confirmed.It is evident that the edge of the liner was loaded by the femoral head and patient body weight while implanted, causing the deformation in the rim of the device.Interlock feature edge of the liner denoted four ard tabs sheared off from the liner which is also evidence of the liner having disassociated from the cup.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 = > product description: pinn mar +4 10d (b)(6).Product code: 121932156 lot number: c75837 please provide: 1) quantity manufactured: 40 2) date of manufacture: 08/2016 3) any anomalies or deviations identified in dhr: none 4) expiry date: 07/2021 5) ifu reference: 090200701 rev p device history review = > a manufacturing record evaluation was performed for the finished device (121932156/c75837) product and lot numbers, and no non-conformances were identified.Corrected h3.

• Brand Name: PINN MAR +4 10D 32IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15223723
• Report Number: 1818910-2022-15772
• Device Sequence Number: 14955884
• Product Code: LPH
• UDI-Device Identifier: 10603295014072
• UDI-Public: 10603295014072
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/15/2022

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: 1219-32-156
• Device Catalogue Number: 121932156
• Device Lot Number: C75837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 11/03/2022; 11/17/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 08/17/2022; 11/04/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL2 NON COL HO SIZE 14.; DELTA CER HEAD 12/14 32MM +9.; PINN MAR +4 10D 32IDX56OD.; PINNACLE SECTOR II CUP 56MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male