MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 66MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-32-066
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The patient underwent primary thr surgery (left hip) on tuesday the (b)(6) 2021.In regards to the post operative component positioning, it's noticeable that the patient has no pubis due to a previous sarcoma, so referencing for cup positioning was challenging.As a result, the primary cup was not placed in an optimal position, and the patient has suffered a subsequent post-operative dislocation.The surgeon elected to revise the hip (revision surgery was performed today ¿ saturday the (b)(6) 2021).Corail stem was upsized to a 14 ho from a 13 std, and the pinnacle cup was removed and revised to a zimmer/biomet g7 cup.
Additional Manufacturer Narrative
(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
The patient underwent primary thr surgery (left hip) on tuesday the (b)(6) 2021.In regards to the post operative component positioning, it's noticeable that the patient has no pubis due to a previous sarcoma, so referencing for cup positioning was challenging.As a result, the primary cup was not placed in an optimal position, and the patient has suffered a subsequent post-operative dislocation.The surgeon elected to revise the hip (revision surgery was performed today ¿ saturday the (b)(6) 2021).Corail stem was upsized to a 14 ho from a 13 std, and the pinnacle cup was removed and revised to a zimmer/biomet g7 cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Visual examination of the provided x-ray image confirmed the reported event.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: PINN SECTOR W/GRIPTION 66MM
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 12828457
• Report Number: 1818910-2021-25341
• Device Sequence Number: 1362117
• Product Code: KWA
• UDI-Device Identifier: 10603295010371
• UDI-Public: 10603295010371
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 10/30/2021

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 Model Number: 1217-32-066
• Device Catalogue Number: 121732066
• Device Lot Number: 8979374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX +4 10D 40IDX66OD; CORAIL AMT COLLAR SIZE 13; DLT TS CER HD 12/14 40MM +1.5; PINN SECTOR W/GRIPTION 66MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Unknown