MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 S-ROM*SLEEVE PRX ZTT, 18B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	52-1483
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
Litigation records received.Ligation alleges personal and economic injuries, elevated cobalt and chromium levels, adverse local tissue reaction, pain, loss of mobility, illnesses, pseudotumor, and injuries.No labs were provided for the alleged elevated metal ions.Operative notes stated that there was a large effusion, there was granulomatous inflammation involving the hip capsule.The abductors were alive and viable.There was mild osteolysis around the proximal medial femur.Revision notes stated that the capsule was patulous and expanded.There was corrosion both at the trunnion and adapter sleeve.The acetabular component was easily removed without bone loss.We inspected the outer surface of the acetabular component.There was no bone on growth, only fibrous material present.The previous acetabular component was in poor position and placed with a high hip center.Doi: (b)(6) 2009, dor: (b)(6) 2019, right hip.
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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12167175
• Report Number: 1818910-2021-15173
• Device Sequence Number: 3704747
• Product Code: LPH
• UDI-Device Identifier: 10603295170631
• UDI-Public: 10603295170631
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: 01/31/2014
• Device Model Number: 52-1483
• Device Catalogue Number: 521483
• Device Lot Number: 2832864
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/11/2021
• 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: ADAPTER SLEEVE 11/13 +6; ASR ACETABULAR CUPS 46; ASR UNI FEMORAL IMPL SIZE 41; S-ROM*SLEEVE PRX ZTT, 18B-SML; SROM*STM ST,30+4L NK,18X13X160; ADAPTER SLEEVE 11/13 +6; ASR ACETABULAR CUPS 46; ASR UNI FEMORAL IMPL SIZE 41; S-ROM*SLEEVE PRX ZTT, 18B-SML; SROM*STM ST,30+4L NK,18X13X160
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR