MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-32-056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/19/2021
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
When stooping at home, patient experienced shooting pain in right hip.Inlay dislocation seen in x-ray.Revision with inlay change on january 19th.
Event or Problem Description
Medical records received.On (b)(6) 2021, the patient underwent a right hip revision to address cup and liner disassociation.The liner was the only product revised.The surgeon noted excision of extensive scarring.There were no indicated intra-operative complications.
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: no device associated with this report was received for examination.The manufacturing records have been reviewed.No related deviations or anomalies were identified.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.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: the manufacturing records have been reviewed.No related deviations or anomalies were identified.Device history review: the manufacturing records have been reviewed.No related deviations or anomalies were identified.

• Brand Name: ALTRX NEUT 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
• MDR Report Key: 11280377
• Report Number: 1818910-2021-02423
• Device Sequence Number: 2564321
• Product Code: LPH
• UDI-Device Identifier: 10603295016137
• UDI-Public: 10603295016137
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2021

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: 1221-32-056
• Device Catalogue Number: 122132056
• Device Lot Number: J6794K
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 04/14/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/25/2021; 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +1 GR; CORAIL2 STD SIZE 13; PINNACLE SECTOR II CUP 56MM; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +1 GR; CORAIL2 STD SIZE 13; PINNACLE SECTOR II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 85