MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-32-058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2020
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 presented with a dislocated total hip construct.The patient was squatting freeweights (300lbs +) when their hip dislocated.Upon review, the surgeon said that the liner dissociated from the pinnacle shell.The surgery was booked, and the dissociated liner removed.The taper of the pinnacle shell appeared to be in good condition.A new liner and femoral head implant were implanted and the surgery completed without issues.The hospital retained the dissociated liner for their implant retrieval laboratory.Information for the following is not available as of yet: date of original surgery, product #s and lot#s of original components.
Event or Problem Description
Additional information received stated that the affected side is the left.There was no surgical delay.
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 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: lot number 629779.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ALTRX NEUT 32IDX58OD
• 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: 10259862
• Report Number: 1818910-2020-15576
• Device Sequence Number: 14219172
• Product Code: LPH
• UDI-Device Identifier: 10603295016144
• UDI-Public: 10603295016144
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• 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): 06/30/2020

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: 1221-32-058
• Device Catalogue Number: 122132058
• Device Lot Number: 629779
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 08/14/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/23/2020; 08/17/2020
• 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: PINN SECTOR W/GRIPTION 58MM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention