MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-058
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526)
Date of Event	02/20/2022
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
Surgeon reported to bfarm: "hip-tep left side on (b)(6) 2021 in (b)(6).Patient now is transferred by ambulance from the (b)(6) clinic in (b)(6).Presentation there because of subluxation phenomena at the left hip joint.He had never been free of discomfort since the operation.Always when climbing stairs and during certain movements and loads, he had heard a creaking noise and had slight pain.So far, he has had the feeling that the hip joint has jumped out six times, but then located back in on its own.Yesterday renewed subluxation phenomenon when bending, this time with severe pain, again snapping back by itself.He now has a considerable feeling of instability and does not dare to make certain movements.No pain at rest.No trauma.Radiological dislocation of the pe.Revision of head and inlay on (b)(6) 2022 in (b)(6)." doi: (b)(6) 2021; dor: (b)(6) 2022; left 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 # (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: d1, d2, d4 (catalog), d10 and g1.
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 : the device associated with this report was not received for analysis.Examination of the returned liner involved in this complaint, could confirmed that the poly liner underwent a disassociation event from the cup.Interlock feature edge of the liner denoted three ard tabs sheared off from the liner which is evidence of the liner having disassociated from the cup.It is not unreasonable that noise would be present due to the ceramic head articulating against the metal cup.However, audible noise 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 : a dhr was performed: 1) quantity manufactured: (b)(4) parts, 2) date of manufacture: 03/nov/2020, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 31/oct/2030, 5) ifu reference: 090200701.Device history review : a manufacturing record evaluation was performed for the finished device (121701058/9627500) product and lot numbers, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Mwr-17052022-0001185278 has been retracted is this was reported in error.The device has not been received and still in transit.

• Brand Name: PINNACLE 100 ACET CUP 58MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork IN ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13719703
• Report Number: 1818910-2022-04380
• Device Sequence Number: 14966245
• Product Code: LPH
• UDI-Device Identifier: 10603295008583
• UDI-Public: 10603295008583
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/10/2022

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: 1217-01-058
• Device Catalogue Number: 121701058
• Device Lot Number: 9627500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 03/21/2022; 04/01/2022; 04/01/2022; 05/17/2022; 06/21/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 03/31/2022; 04/04/2022; 05/17/2022; 05/19/2022; 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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 NON COL HO SIZE 14; DELTA CER HEAD 12/14 32MM +1; PINN MAR NEUT 32IDX58OD; UNK HIP ACETABULAR LINER POLY; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male