MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043 ALTRX +4 NEUT 32IDX52OD; HIP ACETABULAR INSERT/LINER

Catalog Number	122132452
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/13/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Clinical der states that the patient experienced ae for initial dislocation- patient did not fall.Event meets the definition of serious and is considered severe.Event is definitely not related to device and definitely related to procedure.Revision due to dislocation occured on (b)(6) 2017.Depuy left liner and head were revised.Event is considered resolved.It was also reported for an ae experienced hematoma.

• Brand Name: ALTRX +4 NEUT 32IDX52OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• MDR Report Key: 6921927
• Report Number: 1818910-2017-26127
• Device Sequence Number: 13671481
• Product Code: LPH
• UDI-Device Identifier: 10603295016298
• UDI-Public: 10603295016298
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 122132452
• Device Lot Number: D1XAV1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 82