MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN BI-MENTUM HIP ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER BI-ME

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Fall (1848); Fever (1858); Inflammation (1932); Nerve Damage (1979); Pain (1994); Rash (2033); Urticaria (2278); Impaired Healing (2378); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); Muscle/Tendon Damage (4532); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Data use agreement included patients implanted with pinnacle cup, pinnacle dual mobility metal liner, and bi-mentum dual mobility liner between (b)(6) 2020 and (b)(6) 2021 identifying a total of (b)(4) patients.There was no mention of femoral head or stem manufacturer.No patients in this cohort experienced intra-operative complications.Three patients experienced mortality all within 1-year of index surgery at an average of 7.6 months, all due to causes unrelated to the device implanted but due to pre-existing medical co-morbidities or having undergone the tha procedure.A total of (b)(4) patients experienced 32 adverse events (table below).No mention of medical or surgical intervention.Two patients experienced reoperation of which both were due to periprosthetic fracture during an acute episode of alcohol intoxication.Blistering/hives 1 (3.1%).Calf cramping 1 (3.1%).Calf swelling 1 (3.1%).Cellulitis 1 (3.1%).Death 3 (9.4%).Delayed wound healing 1 (3.1%).Ed visit 1 (3.1%).Fall 13 (40.6%).Groin pain/catching sensation 1 (3.1%).Gt bursitis 1 (3.1%).It band tendinitis 1 (3.1%).Limb length discrepancy 1 (3.1%).Pain to incision site 1 (3.1%).Postoperative fever 1 (3.1%).Periprosthetic fracture about tha? 2 (6.3%).Sciatica 1 (3.1%).Surgical site drainage 1 (3.1%).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: although distributed by depuy synthes joint reconstruction, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable device history lot : all batches are released in compliance with supplier specifications.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : although distributed by depuy synthes joint reconstruction, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN BI-MENTUM HIP ACETABULAR LINER
• Type of Device: HIP ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17350173
• MDR Text Key: 319469982
• Report Number: 1818910-2023-14623
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER BI-ME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNKNOWN BI-MENTUM HIP ACETABULAR LINER
• Patient Outcome(s): Required Intervention