MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML SM STATURE 12.0MM; HIP FEMORAL STEM/SLEEVE

Catalog Number	155401120
Medical Device Problem Codes	Naturally Worn (2988); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Not Applicable (3189)
Date of Event	08/23/2017
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
Aug 9, 2017: litigation records received.Litigation alleges defective device, physical and mental pain and debility.Update nov 6, 2017: pfs and medical records received.In addition to what was previously alleged, pfs alleges difficulty in mobility and elevated metal levels.After review of medical records for the mdr reportability, it was reported that the patient was revised to address pain.Revision notes reported elevated metal levels, osteolysis, metal line pseudocapsule, metal debris inside the liner and the trunnion of the femoral neck, and weakness.Part/lot information were provided.This complaint was updated on nov 10, 2017.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Device history lot: null.Device history batch: null.Device history review: null.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
Complaint description: aug 9, 2017: litigation records received.Litigation alleges defective device, physical and mental pain and debility.Update nov 6, 2017: pfs and medical records received.In addition to what was previously alleged, pfs alleges difficulty in mobility and elevated metal levels.After review of medical records for the mdr reportability, it was reported that the patient was revised to address pain.Revision notes reported elevated metal levels, osteolysis, metal line pseudocapsule, metal debris inside the liner and the trunnion of the femoral neck, and weakness.Part/lot information were provided.This complaint was updated on nov 10, 2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Ppf alleges metal wear.Added account name, lawyer and law firm, associated contacts.Updated pateint identifier, remove expiration date, product experience code.Doi: (b)(6) 2008; dor: (b)(6) 2017 (right hip).

• Brand Name: AML SM STATURE 12.0MM
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; 0988; warsaw IN 46582 0988
• MDR Report Key: 7048989
• Report Number: 1818910-2017-29476
• Device Sequence Number: 1259984
• Product Code: JDI
• UDI-Device Identifier: 10603295058229
• UDI-Public: 10603295058229
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2017

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 Expiration Date: 09/01/2018
• Device Catalogue Number: 155401120
• Device Lot Number: C32HF1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 07/23/2018; 08/21/2018; 10/18/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 08/17/2018; 08/31/2018; 10/22/2018
• 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: 64 YR
• Patient Weight: 52