MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 32IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932454
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Joint Laxity (4526)
Date of Event	04/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).E3: the initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.Investigation summary: the device associated with this report was received for examination.Visual examination of the returned device along with photographic evidence did not identify a device issue.It cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.No defects were observed throughout the part.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.Patient contacted dps customer service.He received hip-tep right side on (b)(6) 2016.Revision of hip head and inlay at unknown date in unknown hospital.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.The device associated with this report was received for examination.Visual examination of the returned device along with photographic evidence did not identify a device issue.It cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.It was noted a damage to a portion of the rim which is most likely caused during extraction process.This, does not represent a device failure.A dhr was performed: 1) quantity manufactured: (b)(4).2) date of manufacture: 02/01/2016.3) any anomalies or deviations identified in dhr: none.4) expiry date: 01/31/2021.5) ifu reference: 90200701.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.There is no reported allegation on 121932454/pinn mar +4 neut 32idx54od.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? n/a.Dimensional inspection: n/a.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 02/01/2016.3) any anomalies or deviations identified in dhr: none.4) expiry date: 01/31/2021.5) ifu reference: 90200701.Device history review: a manufacturing record evaluation was performed for the finished device (121932454/733419) product and lot numbers, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Patient contacted dps customer service.He received hip-tep right side on (b)(6) 2016.Revision of hip head and inlay at unknown date in unknown hospital.Updated event description: the patient was revised due to luxation.Doi: (b)(6) 2016.Dor: unknown.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was received for examination.Visual examination of the returned device along with photographic evidence did not identify a device issue.It cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.No defects were observed throughout the part.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 = > 1) quantity manufactured: 20 parts.2) date of manufacture: 02/01/2016.3) any anomalies or deviations identified in dhr: none.4) expiry date: 01/31/2021.5) ifu reference: (b)(4).Device history review a manufacturing record evaluation was performed for the finished device (121932454/733419) product and lot numbers, and no non-conformances were identified.H11 additional narrative:.

• Brand Name: PINN MAR +4 NEUT 32IDX54OD
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19713246
• Report Number: 1818910-2024-14965
• Device Sequence Number: 8575943
• Product Code: LPH
• UDI-Device Identifier: 10603295014348
• UDI-Public: (01)10603295014348(10)733419(17)210131
• 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: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 01/31/2021
• Device Catalogue Number: 121932454
• Device Lot Number: 733419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• 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: APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 9; HIP BALL BIOLOX 32 +5 12/14; PINNACLE 100 ACET CUP 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male