MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Revision of acetabular components of a hip-tep.Doi: unknown.Dor: (b)(6) 2022.Unknown side.
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.Corrected: d10 (the concomitant products were updated form unknown to known products).
Event or Problem Description
Additional information received: a.Was there any adverse consequence/s to the patient that led to the revision surgery? yes, pain when bending.B.Was there a surgical delay? if yes, what is the duration of the delay? no.C.What is the affected side? right side.
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 # (b)(4).Investigation summary : based on the visual analysis of the provided photographic evidence along with observations on the physical examination of involved devices, a disassociation event could be confirmed.There can be observed deformation on the device's rim, most likely caused by the femoral head edge loading.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.Device history lot : bfarm dhr review request: product description: pinn mar +4 neut 32idx50od product code: 121932450 lot number: 179238.Please provide: 1) quantity manufactured: (b)(4).2) date of manufacture: 12/2011 3) any anomalies or deviations identified in dhr: none.No non conformances were identified 4) expiry date: 12/2016 5) ifu reference: 090200701 - ifu tot hip pros rev.L.Device history review : a manufacturing record evaluation was performed for the finished device (121932450/179238) product and lot numbers, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was received for analysis.Based in the visual analysis of the provided photographic evidence along with examination of the part, it was observed that a portion of the liner's rim was fractured.Location of the fracture is consistent with excessive edge loading of the femoral head and patient's body weight since machining lines are yet visible opposite to the fracture zone.Interlock feature edge of the liner denoted three 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 : 1) quantity manufactured: (b)(4) parts 2) date of manufacture: 12/15/2011 3) any anomalies or deviations identified: in dhr: none 4) expiry date: 12/2016 5) ifu reference: 090200701.Device history review : a manufacturing record evaluation was performed for the finished device (121932450/179238) product and lot numbers, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: based on the visual analysis of the provided photographic evidence along with observations on the physical examination of involved devices, a disassociation event could be confirmed.There can be observed a deformation on the device's rim, most likely caused by the femoral head edge loading.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.Device history lot: bfarm dhr review request: product description: pinn mar +4 neut 32idx50od, product code: 121932450, lot number: 179238.Please provide: 1) quantity manufactured: (b)(4), 2) date of manufacture: 12/2011, 3) any anomalies or deviations identified in dhr: none.No non conformances were identified, 4) expiry date: 12/2016, 5) ifu reference: 090200701 - ifu tot hip pros rev.L.Device history review: a manufacturing record evaluation was performed for the finished device (121932450/179238) product and lot numbers, and no non-conformances were identified.

• Brand Name: PINN MAR +4 NEUT 32IDX50OD
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15587603
• Report Number: 1818910-2022-20205
• Device Sequence Number: 17936722
• Product Code: LPH
• UDI-Device Identifier: 10603295014324
• UDI-Public: 10603295014324
• 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: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 1219-32-450
• Device Catalogue Number: 121932450
• Device Lot Number: 179238
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 11/18/2022; 12/01/2022; 02/02/2023; 02/28/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 10/18/2022; 11/18/2022; 12/05/2022; 02/03/2023; 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2011
• 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: APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 9; HIP BALL BIOLOX 32 +5 12/14; PINNACLE SECTOR II CUP 50MM; UNK HIP ACETABULAR AUGMENT; UNK HIP FEMORAL HEAD CERAMIC; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female