MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-152
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	09/01/2020
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
A patient was treated with a hip tep implantation in 2017 and now complained about sudden restriction of range of movement and a squeaking sound in the left hip joint.Intra op x-ray shows an eccentric placement of the hip head and a subluxated inlay with expected pre-damage.X-ray post op inconspicuous.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed a disassociation event.Error in materials or manufacture was not 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: dhr reviewed and the product had one hold to correct paperwork only, no anomalies or deviations for the product was found.Corrected: h3 and h6 by removing pec (implant noise).
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.
Event or Problem Description
Aspiration of left hip occurred on (b)(6) 2020: negative for infection.Revision operative notes (b)(6) 2020 indicate the patient received a left total hip revision due to inability to ambulate, inlay damage and subluxation from the cup (disassociation).Upon entering the joint, it is indicated that there were 2 chips that came off of the inlay, these were removed from the joint.The head and liner were exchanged.The surgery was completed.These revision notes go on to indicate that after a review of the prosthetic stickers when preparing the surgery report on the following morning revealed that the wrong inlay (duraloc) had been inserted into the cup (pinnacle).The patient was informed and a revision was planned.
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.Patient code: removed code for absence of treatment and replaced with no code available (3191) to capture device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN MAR +4 10D 32IDX52OD
• 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: 10606992
• Report Number: 1818910-2020-21231
• Device Sequence Number: 2793802
• Product Code: LPH
• UDI-Device Identifier: 10603295014058
• UDI-Public: 10603295014058
• 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: 2017
• Device Explanted Year: 2020
• 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,Followup,Followup
• Report Date (Section B): 09/17/2020

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 Expiration Date: 03/31/2022
• Device Model Number: 1219-32-152
• Device Catalogue Number: 121932152
• Device Lot Number: H74569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/28/2020; 11/08/2020; 11/17/2020; 12/08/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/13/2020; 11/17/2020; 11/30/2020; 12/10/2020
• 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: CORAIL2 NON COL HO SIZE 10; HIP BALL BIOLOX 32 +9 12/14; PINNACLE SECTOR II CUP 52MM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 72