MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*CUP ACE,ZTT-2 L32,60DP+6; S-ROM HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 557360

Device Problems Malposition of Device (2616); Naturally Worn (2988)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Date 07/09/2020

Event Type  Injury  

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 Description

Clinical adverse event received for poorly positioned acetabular component: abnormal radiographic evaluation.Event is serious and is considered moderate.Event is definitely related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2003.Date of revision: (b)(6) 2014 (acetabular liner and competitor femoral head).Date of event (onset): (b)(6) 2020 (right hip).Treatment: none - awaiting total hip revision.

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.H6 patient code: no code available (3191) was used to capture joint instability.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2003, the patient underwent a right hip revision involving the removal of an unknown hip due to pain, poly wear, and osteolysis.A depuy s-rom 60 mm deep profile +6 ztt cup, with two dome screws and one rim screw, along with one rim pin, and a 32 mm inner diameter 10 degree posterior-lipped +3 lateralized depuy liner were implanted.On the femoral side, howmedica product was implanted.On (b)(6) 2014, the patient underwent a right hip revision due to a worn, fractured, and dislocated liner.The patient was also experiencing grinding and instability.The surgeon noted slight wear on the depuy cup and minimal lysis.The cup was well ingrown and not revised.An s-rom lipped liner was implanted with one locking screw and one locking pin.The surgeon indicated the cup had minimal anteversion, but felt the cup gave the patient good stability with the newly implanted liner.Event is captured on (b)(4).On (b)(6) 2020, the patient presented for a right hip evaluation due to audible popping/clunking, audible and palpable subluxation, possible early osteolysis, poorly positioned cup, and instability.The surgeon indicated the patient was a candidate for revision.There is no evidence of a revision involving this event.Event is captured on (b)(4).

Event Description

The new information provided reports that a hip revision has now occurred on (b)(6) 2020 as treatment for the malpositioned cup, as well as addressing liner bearing wear and hip dislocation/subluxation.Additional coding for impacted products has been initiated to address this revision surgery.No new impacted products are required.As previously noted, the femoral stem and head are competitor devices (stryker).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A review of the provided images is able to confirm, as reported, a mis-positioning of the acetabular cup.Cup placement is determined by the implanting surgeon and is not considered a product problem.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.Removed patient code absence of treatment.H6 patient code: no code available (3191) used to capture the device revision or replacement.

• Type of Device: S-ROM HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10334063
• MDR Text Key: 200666359
• Report Number: 1818910-2020-17012
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 557360
• Device Lot Number: 803685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 07/31/2020; 08/25/2020
• Supplement Dates FDA Received: 08/13/2020; 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: S-ROM*CUP ACE,ZTT-2 L32,60DP+6; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*SCREW,5.0MM DIA,45 MM LG; S-ROM*SCREW,6.5MM DIA,30MM LG; S-ROM*SCREW,6.5MM DIA,35MM LG; S-ROM*SCREW.5.0MM DIA,50 MM LG; SROM MAR LNR L 32MM+3MM 10 DEG; STRYKER HEAD; STRYKER STEM; S-ROM*CUP ACE,ZTT-2 L32,60DP+6; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*SCREW,5.0MM DIA,45 MM LG; S-ROM*SCREW,6.5MM DIA,30MM LG; S-ROM*SCREW,6.5MM DIA,35MM LG; S-ROM*SCREW.5.0MM DIA,50 MM LG; SROM MAR LNR L 32MM+3MM 10 DEG
• Patient Age: 63 YR
• Patient Weight: 109