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

Model Number	1218-32-054
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	10/19/2020
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
Surgeon reported to nca (bfarm): "hip-tep right side 2005 in our hospital.Since (b)(6) 2020 ms.(b)(6) was complaining about strong pain in the right hip.The pain was strong, the ability to walk and stand was completely eliminated.The patient alerted the ambulance, who finally brought her in.The pain was not possible to be managed on an outpatient basis.On the other hand she has been very satisfied with the right hip replacement over the years.Two years ago a hip-tep of left hip took place.This one was followed by 2 additional surgical interventions due to infection.Radiological polyerthylene dislocation of right hip-tep.Change of polyethylene and hip-head on (b)(6) 2020.".
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported allegations.A second review of the attached x-rays confirmed that there was a disassociation event following the reported dislocation.A root cause could not be determined.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 has been reviewed and no deviations or anomalies were found that would contribute to reported allegations.Corrected: h3.

• Brand Name: PINN LINER 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
• MDR Report Key: 10808876
• Report Number: 1818910-2020-24167
• Device Sequence Number: 17166263
• Product Code: LPH
• UDI-Device Identifier: 10603295011552
• UDI-Public: 10603295011552
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 10/22/2020

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 Model Number: 1218-32-054
• Device Catalogue Number: 121832054
• Device Lot Number: Z1GDG1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/18/2020; 11/18/2020; 12/15/2020; 01/20/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/19/2020; 11/24/2020; 12/22/2020; 01/20/2021
• 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: DURALOC- APEX HOLE ELIMINATOR NEW.; METAL FEMORAL HEAD, TAPER 12/14, 32MM+5.0MM.; S-ROM SHAFT, 12/14, STD, 16X11X150 / 36MM.; S-ROM ZTT PROX. SLEEVE 16D-LRG.; UNK HIP ACETABULAR LINER METAL.; UNKNOWN HIP FEMORAL HEAD.; UNK HIP ACETABULAR LINER METAL; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR